FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MECONIUM ASPIRATOR
K Number: K893649
·
Decision Aug 21, 1989
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
75
Review Days
98
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Basic Information
- Device Name
- MECONIUM ASPIRATOR
- K Number
- K893649
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Gish Biomedical, Inc.
- Date Received
- May 15, 1989
- Decision Date
- August 21, 1989
- Product Code
- GCX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K083131 | MEDOS HILITE RESERVOIR, MODEL: 4030 | Jul 30, 2009 | Substantially Equivalent |
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| K082082 | GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING | Feb 4, 2009 | Substantially Equivalent |
| K081947 | GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING | Feb 4, 2009 | Substantially Equivalent |
| K080708 | VISION HOLLOW FIBER OXYGENATOR WITH HA COATING | Feb 2, 2009 | Substantially Equivalent |
| K081838 | GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING | Jan 26, 2009 | Substantially Equivalent |
| K081881 | GISH TUBING AND CONNECTORS WITH HA COATING | Jan 23, 2009 | Substantially Equivalent |